On November 20, 2025 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported the closing of its previously announced underwritten public offering of 11,500,000 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 1,500,000 additional shares of common stock, at a price to the public of $19.00 per share. The gross proceeds to Olema from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $218.5 million.

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TD Cowen, Evercore ISI, Guggenheim Securities, LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. acted as book-running managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed with the Securities and Exchange Commission (the "SEC") on January 6, 2025 and declared effective on January 15, 2025, and a related registration statement on Form S-3MEF that was filed with the SEC pursuant to Rule 462(b) on November 18, 2025, which became automatically effective on November 18, 2025. Copies of the final prospectus supplement and accompanying prospectus relating to the offering can be accessed at no charge through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Olema Oncology, NOV 20, 2025, View Source [SID1234660848])

On November 20, 2025 GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its third quarter 2025 financial results1 and provided a corporate update.

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Cash Position

As of September 30, 2025, the Company’s cash and cash equivalents amounted to €119.0 million compared with €107.5 million as of June 30, 2025, and €81.8 million as of December 31, 2024.

We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the end of 2028, enabling the Company to further develop its pipeline focused on Acute on-Chronic Liver Failure (ACLF) and support general corporate purposes. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes (i) our expectation to receive significant future commercial milestone revenue pursuant to the license agreement with Ipsen and Ipsen meeting its sales-based thresholds and (ii) drawing down all additional installments under the Royalty Financing agreement with HCRx.

In the first nine months of 2025, cash utilization is mainly the result of our research and development efforts in our pipeline focused on ACLF (notably VS-01, G1090N2, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization was notably offset by a €26.5 million milestone payment received in July 2025 under the Licensing and Collaboration Agreement with Ipsen, following pricing and reimbursement approvals for Iqirvo (elafibranor) in three major European markets3.

Revenue

Revenue4 for the first nine months of 2025 amounted to €39.2 million compared to €59.7 million for the same period in 2024.

Revenue for the first nine months of 2025 was primarily driven by the Licensing and Collaboration Agreement with Ipsen, including (i) royalty revenue from worldwide sales (excluding Greater China) of Ipsen’s Iqirvo (elafibranor) totaling €12.6 million and (ii) milestone revenue from pricing and reimbursement approval of Iqirvo (elafibranor) in three major European countries3 totaling €26.5 million.

Program highlights

ACLF pipeline

G1090N2 – A Phase 1 First-in-Human study in healthy volunteers is currently underway with safety data expected at the end of this year. Early signals of efficacy from ex-vivo functional assays are also expected at the same time.

SRT-015 – Current work on an improved formulation aims at increasing exposure. Pending positive development, the launch of a first-in-human trial could be initiated as early as the second half of 2026.

CLM-022 – Current experiments aim at confirming therapeutic efficacy using different disease models relevant for AD and ACLF as well as starting formulation development and first toxicological studies in 2025. Pending further positive developments, a first-in-human trial could be initiated in the first half of 2027.

VS-02-HE – We intend to develop VS-02-HE as a unique oral formulation designed to act in the gut where ammonia is primarily produced, minimizing systemic absorption of ammonia while reducing glutamine levels in the brain. Completion of Investigational New Drug-enabling nonclinical studies and formulation development are expected by the end of 2025. A first-in-human trial could be initiated in the second half of 2027.

Other life-threatening diseases

GNS561 in CCA – Data readout from the ongoing Phase 1b clinical trial are expected by the end of 2025.

VS-01-HAC in Urea Cycle Disorders & Organic Acidemias (pediatric indication) – Data from the pivotal juvenile toxicology study in Göttingen Minipigs are expected before the end of 2025. Following discontinuation of VS-01 in ACLF, additional preclinical work will be conducted before moving into the clinic. Update on the ongoing preclinical work and potential clinical development is expected before the end of 2025.

Primary Biliary Cholangitis (PBC)

As reported in Ipsen’s third quarter financial results5, Iqirvo (elafibranor) continues to show solid growth across both the U.S. and European markets in PBC.

(Press release, Genfit, NOV 20, 2025, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-third-quarter-2025-financial-information-and [SID1234660847])

On November 20, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported the first patient has been randomized in the pivotal Phase 3 CAREFNDR trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of once-daily, oral paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The Phase 3 study builds on positive Phase 2 data in which paltusotine demonstrated rapid and sustained reductions in the frequency and severity of carcinoid syndrome symptoms, including flushing episodes and bowel movements.

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"Patients with carcinoid syndrome need a treatment option that can consistently manage symptoms without the burden of painful monthly injections," said Dana Pizzuti, M.D., Chief Medical and Development Officer of Crinetics. "Based on our encouraging Phase 2 results and data from our open-label extension, we believe paltusotine has the potential to transform the treatment landscape with a once-daily, oral therapy that may offer meaningful benefits for patients managing the challenging day-to-day impacts of carcinoid syndrome. The initiation of our Phase 3 CAREFNDR trial represents a significant milestone in our commitment to address this critical unmet need."

The Phase 3 study is designed to enroll 141 adults, both naïve and previously treated patients, with carcinoid syndrome. Participants will be randomized in a 2:1 ratio to receive either once-daily paltusotine 80 mg or matching placebo. The primary endpoint will measure the change in flushing episodes per day from baseline to Week 12, with change in bowel movements per day as a key secondary endpoint. Following the 16-week randomized controlled period, the trial includes a 104-week open-label extension (OLE) to evaluate long-term efficacy, safety and additional clinical outcomes. The OLE will also monitor long-term tumor control (progression free survival).

The Phase 3 CAREFNDR trial represents the latest step in Crinetics’ goal of expanding the value of PALSONIFY (paltusotine) beyond its lead indication for the treatment of acromegaly. Crinetics is also investigating meeting the unmet needs of NETs patients through CRN09682, the first candidate from its nonpeptide drug conjugate platform. CRN09682, an investigational anti-tumor candidate targeting SST2-expressing neuroendocrine and other solid tumors, received Investigational New Drug clearance earlier this year. This broader development strategy reflects Crinetics’ dedication to developing transformative therapies that address serious endocrine disorders and endocrine-related cancers.

For more information about the CAREFNDR trial, visit View Source Global enrollment in CAREFNDR is expected throughout 2025 and 2026.

About Paltusotine
Paltusotine, a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide, is in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors (CAREFNDR). Results from a Phase 2 study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency, which are the most common symptoms of carcinoid syndrome. PALSONIFY (paltusotine) is currently approved in the U.S. for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

About Carcinoid Syndrome
Carcinoid syndrome is found in approximately 20% of patients with neuroendocrine tumors (NETs). NETs are a rare, slow-growing type of cancer that arise most often in the digestive tract. When these tumors metastasize to the liver, carcinoid syndrome can occur and is most commonly characterized by diarrhea and flushing. While injectable depot somatostatin receptor ligand therapies are mainstay treatments for carcinoid syndrome, these injections are associated with considerable treatment burden and offer inadequate relief of carcinoid syndrome symptoms for many patients.

(Press release, Crinetics Pharmaceuticals, NOV 20, 2025, View Source [SID1234660846])

On November 20, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on October 3, 2025 for FoundationOneCDx Cancer Genomic Profile to be used as a companion diagnostic for Augtyro (repotrectinib), an anti-cancer agent/tyrosine kinase inhibitor for NTRK fusion-positive solid-tumors. Bristol-Myers Squibb K.K. obtained a partial change approval for the manufacturing and marketing authorization of Augtyro in Japan.

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"We are pleased that FoundationOne CDx Cancer Genomic Profile was approved as a companion diagnostic for repotrectinib for identifying NTRK fusion-positive solid-tumors patients. We believe that being able to comprehensively identify with a single comprehensive genomic profiling test, rare genetic mutations that occur at low frequencies across cancer types, such as NTRK fusion genes, is useful for informing optimal treatment plans for patients. We will continue to contribute to the advancement of personalized healthcare based on each patient’s genetic mutation status by expanding companion diagnostics," said Dr. Osamu Okuda, Chugai’s President and CEO.

This approval enables the detection of NTRK1/2/3 fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use repotrectinib for NTRK fusion-positive solid-tumor patients. The efficacy and safety of repotrectinib for NTRK fusion-positive advanced or recurrent solid-tumors were evaluated in the international Phase I/II clinical study (TRIDENT-1) and overseas Phase I/II pediatric clinical study (CARE). Bristol Myers Squibb K.K. obtained approval from the MHLW on November 20, 2025.

As a oncology leading company, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of Comprehensive Genomic Profiling.

Approval information The underlined and bolded part has been newly added.

Intended uses or indications

The product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate, dacomitinib hydrate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib, encorafenib, binimetinib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
AKT1 alterations capivasertib
PIK3CA alterations
PTEN alterations
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
Tumor mutational burden high pembrolizumab (genetical recombination)
NTRK1/2/3 fusion genes entrectinib, larotrectinib sulfate, repotrectinib
RET fusion genes selpercatinib
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib, talazoparib tosilate
FGFR2 fusion genes Biliary tract cancer pemigatinib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, NOV 20, 2025, View Source [SID1234660845])

On November 20, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Nippon Shinyaku Co., Ltd. (TOKYO: 4516) reported that the electronic package insert for the anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva Intravenous Infusion 1000 mg [generic name: obinutuzumab (genetical recombination)] has been revised to allow combination therapy with the anti-cancer agent/BCL-2 inhibitor Venclexta Tablets 10 mg, 50 mg, and 100 mg [generic name: venetoclax] for previously untreated CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma).

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This revision of the electronic package insert is based on the results of clinical studies evaluating the efficacy and safety of combination therapy with venetoclax and obinutuzumab for previously untreated chronic lymphocytic leukemia (including small lymphocytic lymphoma). These include a Japanese Phase II clinical study (M20-353) conducted by AbbVie GK and a global Phase III clinical study (CLL14/BO25323) conducted by Roche in cooperation with AbbVie Inc. and the German CLL Study Group from the University of Cologne.

Approval Information *Excerpt of relevant sections; underlined portions indicate changes

Before Revision After Revision
7. Precautions Concerning Dosage and Administration

7.1-7.2 (Omitted)

7.3-7.5 (Omitted)

7.6 Initiate administration of this product after 28 days of acalabrutinib treatment.

7.7-7.8 (Omitted) 7. Precautions Concerning Dosage and Administration

7.1-7.2 (Omitted)

7.3-7.5 (Omitted)

7.6 When used in combination with acalabrutinib, initiate administration of this product after 28 days of acalabrutinib treatment.
7.7-7.8 (Omitted)
7.9 For dosage and administration when used in combination with venetoclax, refer to the electronic package insert for venetoclax.
About the Japanese Phase II Clinical Study (M20-353)1
M20-353 study is an uncontrolled, open-label Japanese Phase II clinical study to evaluate the efficacy and safety of venetoclax in combination with obinutuzumab and venetoclax in combination with ibrutinib in Japanese patients with treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The primary endpoint was the rate of complete response (CR) and complete response with incomplete bone marrow recovery (CRi) as assessed by an Independent Review Committee (IRC).

About the Global Phase III Clinical Study (CLL14 Study, BO25323)2
CLL14 Study (BO25323) is a multicenter, randomized, open-label global Phase III clinical study comparing venetoclax in combination with obinutuzumab versus obinutuzumab in combination with chlorambucil (not approved in Japan) in patients with treatment-naïve CLL. The primary endpoint was progression-free survival (PFS) as assessed by investigators.

About Gazyva (obinutuzumab)3
Gazyva is a glycoengineered type II anti-CD20 monoclonal antibody designed to bind to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva is designed to attack and destroy targeted B cells both directly and together with the body’s immune system. Chugai and Nippon Shinyaku jointly develop and market the product in Japan.

About Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
In CLL, blood stem cells in the bone marrow become excessive abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets4. This could result in anemia, infection, and bleeding. SLL is the same type of cancer as CLL. When lymphocytes are not located in the peripheral blood or bone marrow, the disease is called SLL5. CLL/SLL is a rare type of lymphoma accounting for less than one case in 100,000 population annually in Japan.

(Press release, Chugai, NOV 20, 2025, View Source [SID1234660844])